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PHARMACY IV ADMIXTURE

Pharmacy 483

January 18, 2007

Kim Donnelly

Affiliate Assistant Professor

kimdon@u.washington.edu

Pharmacist is responsible for ensuring that

compounded sterile preparations are

properly prepared, labeled, stored,

dispensed and delivered.

USP

ASHP

NABP

JCAHO

Centralized IV Admixture

Service

Economical

Batch preparation

Reduce personnel time

Enhanced safety with standardizedsolutions.

Double check process on all preparedsolutions.

Cleaner, more controlled environment.

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USP-797

New standards effective Jan 2004 but undercontinual revision.

Standards will be enforced by Boards ofPharmacy.

Sterile product preparations are categorizedas high, medium or low risk based on thepotential for microbial, chemical andphysical contamination.

Buffer Room (Prep Area)

Must be ISO Class 7 (Class 10,000)

Prepared in a ISO Class 5 (Class 100)

laminar airflow hood.

Positive pressure room with HEPA filtered

air.

Access is restricted in Buffer area.

ISO Class 7

Also referred to as a Class 10,000

environment.

Air particle count does not exceed 10,000

particles 0.5 microns or larger per cubic

foot of air.

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Buffer Rooms

Walls, floors, ceiling should be smooth, no

cracks and crevices.

Ceilings should be sealed.

Floors coved.

No sinks in Buffer area.

Only non-shedding paper products in area.

Ante-Room or Ante-Area

Gowning and hand-washing.

No food or beverages.

No carts moving back and forth from buffer

zone to ante-area.

Wipe down of products before introducing

into the buffer area.

Laminar Flow Hoods

Horizontal

Vertical

Barrier Isolators

Certified every 6 mo.

ISO Class 5 (Class

100) environment.

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Gowning

Remove make-up, jewelry.

Scrub hands and arms to elbow.

Non-shedding gown, knee length with a zip

or snap front.

Shoe covers, hair covers, face mask and

gloves.

Risk Classification

Non-sterile ingredients or

open-system transfers.

High-Risk Compounding

Admixtures using

multiple additives or

batch preparations.

Medium-Risk

Compounding

Simple admixtures using

closed system transfer

methods.

Low-Risk Compounding

Beyond-Use Dating

Storage period before administration.

When compounded sterile products are

stored for prolonged periods of time there is

potential for microbial growth and pyrogen

formation.

Chemical stability

Microbial sterility

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Beyond-Use Dating

45 days3 days24 hrsHigh

45 days9 days30 hrsMedium

45 days14 days48 hrsLow

FreezerRefrigerationRoom TempRisk Level

Personnel

Documented education, training and

competency.

Didactic training.

Competency tests.

Return demonstration/observation.

Media-fill testing of aseptic manipulative skills.

Media-fill test kit

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Media-fill challenge testing

Sterile bacterial culture medium transferredvia a variety of aseptic manipulations

Test should represent the most challengingproducts made for a particular risk level

Products are monitored for microbialgrowth, indicated by visual turbidity, for 14days

Done annually and for new employees

Environmental Controls and

Testing

Routine cleaning schedule.

Laminar flow hood certification every 6

months.

Particle-count testing.

Electric air samplers or agar settling plates.

Total Parenteral Nutrition

Multiple ingredients (1-3 liters).

Standard Operating Procedures.

Automated Compounders

Improve accuracy and efficiency.

Accuracy verified by weight, volume.

Some hospitals have decided to outsource thesepreparations to compounding centers.

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Hazardous Drugs

NIOSH (National Institute for Occupational

Safety and Health) Guidelines, ASHP Guidelines

for employee safety.

Vertical flow hood vented to the outside to protect

operator.

Pharmacy attaches tubing to reduce RN exposure.

Negative pressure room.

Separate storage/Receiving procedures.

Resources

United States Pharmacopeia (USP) web site:

www.usp.org

American Society of Health-System Pharmacists

(ASHP) web site: www.ashp.org

Kastango ES, Blueprint for implementing USP

chapter 797 for compounding sterile preparations,

AmJ Health-Syst Pharm. 2005;62:1271-88.